Global Development Lead, Internal Medicine (Sr. Director)

The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. The individual will lead the cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues in the design, execution and interpretation of studies in support of worldwide regulatory submissions.

Responsibilities

Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview; In support of assigned projects, provide input for target product profile(s), and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports; Partners effectively with the Prod Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget; Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents; Provides product/program specific input for target product profile(s); Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies; Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches; Partners with Trial clinicians on governance reviews (incl Sci/Ops) for assigned clinical studies; Provides therapy area/indication expertise in support of clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events as required; Provides specialized medical monitoring support for individual trial team, if required; Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programing; Develops submission level deliverables (IAP, IARP and submission TLFs); Responsible for submission deliverables including SCE and SCS; Support appropriate interpretation and communication of clinical trial data; Review and approve submission level safety narrative plan; Supports product label development and maintenance; Engage key external stakeholders e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development; Provides regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense; Ensures compliance with internal SOPs and external regulatory standards; Review IIR proposals

Requirements

BS with 12 yrs or PhD with 7 yrs, relevant clinical/industry experience; Experience leading cardiometabolic late-stage development programs, including type 2 diabetes; Relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development; Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management; Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer; Demonstrated experience managing and training large teams in clinical development; Medical / Scientific credibility/Excellence; Management experience; Leadership; Influencing; Conflict Management; Team Building; Accountability; Change agile; Candidate demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact; Candidates must be authorized to be employed in the U.S. by any employer; Up to 30% travel may be required

Nice to have

Demonstrated experience in designing and launching large teams preferred

Benefits

401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution; paid vacation, holiday and personal days; paid caregiver/parental and medical leave; health benefits to include medical, prescription drug, dental and vision coverage; eligibility for Pfizer's Global Performance Plan with a bonus target of 22.5% of the base salary; eligibility to participate in share based long term incentive program; relocation support available; relocation assistance may be available based on business needs and/or eligibility